Remote Senior Regulatory Documents Specialist

BeOne Medicines Ltd.; Texas; Hybrid; USD 82,000 - 112,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee and coordinate appendices for regulatory submissions, working within the Global Medical Writing team.

The role supports high-quality, compliant documents under ICH and FDA guidelines, with the option to work remotely or from BeOne’s global offices. The ideal candidate will manage timelines, perform quality checks, and engage with cross-functional teams while advancing knowledge in medical writing and regulatory affairs.

Qualifications

• Excellent English communication, written and verbal.
• Ability to prioritize tasks and multitask to meet tight timelines.
• Understanding of FDA regulations and ICH guidelines.
• Experience with regulatory submissions and medical writing preferred.

Responsibilities

• Coordinate and collect appendices for regulatory submissions per ICH.
• Manage appendices timelines and communicate with Medical Writers and cross-functional teams.
• Operate in Veeva Vault to import/export, initiate and approve workflows.
• Perform quality checks on appendices documents.
• Assist in SOP/WI updates and document development within DS scope.

Skills

English communication

Prioritization

Multitasking

Cross-functional collaboration

Education

Masters degree

BA/BS + 2+ years relevant experience

PhD/PharmD or other graduate degree a plus

Tools

Veeva Vault

Microsoft Word

Microsoft Excel

PowerPoint

Adobe Acrobat

SharePoint

Job description

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee and coordinate appendices for regulatory submissions, working within the Global Medical Writing team.

The role supports high-quality, compliant documents under ICH and FDA guidelines, with the option to work remotely or from BeOne’s global offices. The ideal candidate will manage timelines, perform quality checks, and engage with cross-functional teams while advancing knowledge in medical writing and regulatory affairs.